Noah Medical
Sr. RA Specialist
San Jose, California · Senior
Sponsorship not specifiedDetected 22 days ago
ComplianceProduct ManagementFDA RegulatoryMedical DevicesLeadership
About the role
- Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics.
- We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us.
- Utilizing a data-driven approach, we tackle challenges and fuel innovation.
Responsibilities
- Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement.
- Provide regulatory guidance to cross-functional teams throughout product development, design changes, and sustaining engineering activities.
- Participate in design reviews and product development activities to ensure regulatory requirements are incorporated.
- Support compilation and maintenance of Design and Development Files (DDF), Technical Documentation, and regulatory submission dossiers.
- Support implementation of new regulatory requirements within the Quality Management System (QMS).
- Maintain product registrations, licenses, and regulatory approvals.
Requirements
- Prepare and submit regulatory submissions including FDA 510(k)s, international registrations, technical documentation, and other regulatory filings as required.
Benefits
- Support development and execution of global regulatory strategies for new and existing medical devices.
Company info
- Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
- About The Team
- Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!
- A Day In The Life Of Our Sr. RA Specialist
- Noah Medical is building the future of medical robotics.
- Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications.
- We are looking for exceptional engineers and key team members.
- Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen.
- We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
- Regulatory Strategy & Product Development
- Assess regulatory impact of product, process, labeling, software, and manufacturing changes.
- Regulatory Submissions & Registrations
- Coordinate submission activities with regulatory agencies, notified bodies, and international regulatory authorities.
- Track submission status and ensure timely responses to regulatory inquiries.
- Regulatory Compliance
- Monitor and interpret evolving regulatory requirements and standards, including FDA, EU MDR, ISO 13485, MDSAP, and other applicable regulations.
- Ensure ongoing compliance with global regulatory requirements throughout the product lifecycle.
- Labeling & Promotional Review <span data-ccp-props="{"134233117"
Apply directly at Noah Medical →Create a free account for alerts like thisView Noah Medical immigration profile
This listing is sourced directly from Noah Medical's careers page and normalized into a canonical job model.